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Azurion 7 B12

by Philips Medical Systems Nederland B.V. Netherlands EUDAMEDGUDID

Ref 722067

Product code OWBEMDN Z11030103

Regulatory status

as of 24 Oct 2026

Recall ongoing. 41 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884838085350 Basic UDI-DIDate26 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838085350 UDI-DIDate4 Dec 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

44 recalls · 41 ongoing · FDA

    • Ongoing Z-2931-2026 FDA Class II initiated 16 Jul 2026

    Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

    • Ongoing Z-2892-2026 FDA Class II initiated 17 Jun 2026

    Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

    • Ongoing Z-2225-2026 FDA Class II initiated 28 Apr 2026

    Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

    • Ongoing Z-2170-2026 FDA Class II initiated 31 Mar 2026

    Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

  • 8 recalls, same reason

    • Ongoing Z-1344-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1350-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1346-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1347-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1348-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1351-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1349-2026 FDA Class II initiated 26 Jan 2026
    • Ongoing Z-1345-2026 FDA Class II initiated 26 Jan 2026

    Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

    • Ongoing Z-1091-2026 FDA Class II initiated 12 Dec 2025

    Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

    • Ongoing Z-2502-2025 FDA Class II initiated 1 Aug 2025

    Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

    • Ongoing Z-2134-2025 FDA Class II initiated 4 Jun 2025

    Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

    • Ongoing Z-1969-2025 FDA Class II initiated 28 May 2025

    A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

  • 9 recalls, same reason

    • Ongoing Z-1156-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1142-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1154-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1157-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1160-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1153-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1144-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1158-2025 FDA Class I initiated 13 Jan 2025
    • Ongoing Z-1159-2025 FDA Class I initiated 13 Jan 2025

    Possibility of the patient falling from the table related to the mattress used on the patient table.

  • 3 recalls, same reason

    • Ongoing Z-1092-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1093-2025 FDA Class II initiated 13 Jan 2025
    • Ongoing Z-1094-2025 FDA Class II initiated 13 Jan 2025

    Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

    • Ongoing Z-1145-2024 FDA Class II initiated 2 Jan 2024

    Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

    • Ongoing Z-1152-2024 FDA Class II initiated 2 Jan 2024

    Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

  • 8 recalls, same reason

    • Ongoing Z-2286-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2289-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2291-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2287-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2290-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2288-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2284-2026 FDA Class II initiated 7 Dec 2023
    • Ongoing Z-2285-2026 FDA Class II initiated 7 Dec 2023

    During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

    • Ongoing Z-2403-2023 FDA Class II initiated 19 Jul 2023

    A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

    • Ongoing Z-0874-2022 FDA Class II initiated 2 Feb 2022 via K172822, on the same 510(k)

    Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

    • Ongoing Z-0886-2022 FDA Class II initiated 26 May 2021

    In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

    • Terminated Z-1145-2020 FDA Class II initiated 23 Dec 2019

    Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

    • Terminated Z-2205-2019 FDA Class II initiated 16 Jul 2019

    The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.

    • Terminated Z-1997-2019 FDA Class II initiated 30 Nov 2018

    Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Azurion 7 B12 EUDAMED
Azurion GUDID
Generic Name
Stationary angiographic x-ray system, digital
Device Name
Azurion series
Model / Ref / Catalog
722067, Azurion 7 B12
Primary DI / UDI-DI
00884838085350
Basic UDI-DI
B-00884838085350
FDA Product Code
OWB, JAA
EMDN Code
Z11030103 Biplanar angiography systems
GMDN Term
Stationary angiographic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
722067
GUDID
Azurion 7 B12
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Serial Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 95a01491-08d8-4d9d-aa23-3cc8b0bcede2 61 fields · synced 22 Oct 2026
  • FDA UDI 2897cbc1-242b-4720-a046-84d0856f501a 34 fields · synced 30 May 2026